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Programme of Lifestyle Intervention in Families for Cardiovascular Risk Reduction

NCT02771873 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1678

Last updated 2021-01-19

No results posted yet for this study

Summary

The overall goal of the study is to test the effectiveness and sustainability of an integrated care model for managing cardiovascular risk in individuals with family history of premature coronary heart disease (CHD).

This care model involves:

1. screening for cardiovascular risk factors,
2. providing lifestyle interventions for prevention and management of cardiovascular risk factors,
3. providing a framework for linkage to appropriate primary health care facility and
4. active follow-up of intervention adherence.

Initially, a formative qualitative research component will gather information on understanding of diseases, barriers to care, specific components of the intervention package (for example, context specific ways to enhance physical activity and to reduce prolonged sitting time, ways to improve diet etc.) and feedback on the intervention strategies (lifestyle education, care and linkage coordination). Then a randomized controlled trial involving \~700 families and 1400 participants will be used to determine whether an integrated care model is effective in reducing or halting the progression of CHD risk factors and risk factor clustering in families. The sustainability and scalability of this intervention will be assessed through economic and qualitative lenses to estimate value and acceptability. Scalability will be informed by cost-effectiveness and acceptability of the integrated cardiovascular risk reduction approach.

Conditions

Interventions

BEHAVIORAL

Integrated cardiovascular disease risk management.

Health promotion intervention

Sponsors & Collaborators

  • Sree Chitra Tirunal Institute for Medical Sciences & Technology

    collaborator OTHER_GOV

  • Public Health Foundation of India

    lead OTHER

Principal Investigators

  • Panniyammakal Jeemon, Ph.D · Public Health Foundation of India

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2021-01-14
Completion
2021-01-14

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02771873 on ClinicalTrials.gov